Clinical Comparison of Two Soft Contact Lenses

NCT ID: NCT06251154

Last Updated: 2024-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-11
• Study Completion Date: 2024-01-08

Brief Summary

This study was designed to gather short-term clinical performance data for 2 soft contact lenses.

Detailed Description

The purpose of this participant-masked, non-randomized, crossover controlled, non-dispensing, study was to compare the short-term performance of 2 daily disposable contact lenses after 15 minutes of daily wear each. The lenses were identical in all aspects except for diameter. Participants attended for 1 visit only which lasted for approximately 2 hours.

Conditions

Myopia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Lens 1

All participants wore Lens 1 for 15 minutes (Period 1)

Group Type: EXPERIMENTAL

Lens 1

Intervention Type: DEVICE

Daily disposable silicone hydrogel contact lens (diameter=14.0mm) for 15 minutes

Lens 2

All participants wore Lens 2 for 15 minutes (Period 2)

Group Type: EXPERIMENTAL

Lens 2

Intervention Type: DEVICE

Daily disposable silicone hydrogel contact lens (diameter=14.1mm) for 15 minutes

Interventions

Lens 1

Daily disposable silicone hydrogel contact lens (diameter=14.0mm) for 15 minutes

Intervention Type: DEVICE

Lens 2

Daily disposable silicone hydrogel contact lens (diameter=14.1mm) for 15 minutes

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Subjects will only be eligible for the study if:

1. They were of legal age (18) and capacity to volunteer.

2. They understood their rights as a research subject and were willing and able to sign a Statement of Informed Consent.

3. They were willing and able to follow the protocol.

4. They were wearing soft contact lenses, or had done so within the past two years.

5. They were able to be fitted with the study lenses within the power range available.

Exclusion Criteria

• Subjects will not be eligible if:

1. They had an ocular disorder which would normally contra-indicate contact lens wear.

2. They had a systemic disorder which would normally contra-indicate contact lens wear.

3. They were using any topical medication such as eye drops or ointment.

4. They were aphakic.

5. They had had corneal refractive surgery.

6. They had any corneal distortion resulting from previous hard or rigid lens wear or had keratoconus.

7. They were pregnant or lactating.

8. They had an eye or health condition including an immunosuppressive or infectious disease which could, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or a history of anaphylaxis or severe allergic reaction.

9. They had taken part in any contact lens or care system clinical research within two weeks prior to starting this study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CooperVision, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carole Maldonado-Codina, PhD MCOptom

Role: PRINCIPAL_INVESTIGATOR

Eurolens Research

Locations

Eurolens Research

Manchester, , United Kingdom

Countries

United Kingdom

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

EX-MKTG-154

Identifier Type: -

Identifier Source: org_study_id